Use of ctDNA for Monitoring of Stage III Colorectal Cancer | NCT02842203

Studies
Use of ctDNA for Monitoring of Stage III Colorectal Cancer

NCT02842203

Sponsor

University of Pittsburgh

Status

Active, not recruiting

Last Update Posted

Nov 6, 2025Actual

Enrollment

137Actual

Phase

Not provided

Conditions

Stage III Colorectal Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U01CA152753	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Jul 20, 2016

First Submission Date that Met QC Criteria

Jul 21, 2016

First Posted Date

Jul 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2025

Last Update Posted Date

Nov 6, 2025Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker and as a monitor of disease recurrence in stage III colorectal cancer (CRC).

Detailed Description

Circulating tumor DNA (ctDNA) are small fragments of nucleic acid that originate from apoptotic or necrotic tumor cell turnover. Characteristic of the malignant process, ctDNA can be assessed in plasma and offers the potential of a sensitive and specific biomarker for prognostic information on disease-free or overall survival, and predictive information on chemotherapy resistance and probability of lack of response to treatment. This study will evaluate ctDNA as a prognostic marker and as a monitor of disease recurrence in stage III colorectal cancer (CRC). We will recruit newly diagnosed stage III CRC patients, determine their tumor mutational profile, and systematically collect high volume (>10 ml), serial plasma specimens every 3 months for up to 3 years and every 6 months in years 4-5 for ctDNA and concurrent carcinoembryonic antigen (CEA) measurement. Clinical outcome and survival will be tracked. The resulting data will permit assessment of ctDNA as a prognostic marker for disease-free and overall survival and as a monitor of disease recurrence in comparison with CEA.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

137Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ctDNA assessment and relation to clinical outcome	The relationship between ctDNA and survival (both progression-free and overall) will be evaluated. Both the total load of ctDNA and the specific mutation(s) identified will be evaluated.	up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
ctDNA versus CEA	ctDNA predictors of outcome will be compared to CEA	up to 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women with CRC Stage III A, B, or C
Age ≥18 years
Willingness to provide blood samples for research purposes
Ability to understand written informed consent document, and written informed consent provided

Exclusion Criteria:

Blood sampling would compromise patients overall health such as presence of severe anemia
Unable to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who present in a UPMC Cancer Center and meet the criteria for this study will be approached by their treating physician about participation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Schoen, MD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh Medical Center		Pittsburgh	Pennsylvania	15232	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39487920	Derived	Borhani AA, Zhang P, Diergaarde B, Darwiche S, Chuperlovska K, Wang SC, Schoen RE, Su GL. Role of tumor-specific and whole-body imaging biomarkers for prediction of recurrence in patients with stage III colorectal cancer. Abdom Radiol (NY). 2025 May;50(5):1907-1915. doi: 10.1007/s00261-024-04656-3. Epub 2024 Nov 2.

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site